Trial document




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  DRKS00013045

Trial Description

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Title

Study on therapeutic decisions of patients with prostata carcinoma and their partners

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Trial Acronym

Propair

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URL of the Trial

http://-

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Brief Summary in Lay Language

The choice of the right therapy is associated with different expectations and hopes of prostata cancer patients as well as for their partners. So far their are particularly studies on the therapeutic decision-making of patients with first diagnosis of non-metastatic prostata carcinomas available. Increasing life expactancy and improved therapeutic options mean that older patients in an advanced stage of disease are progressively choosing between different oncological therapies. In these patients there are no study results available on the importance of the partnership. The main objective of the study is to record and describe the process of the therapy decision of patients with advanced prostata cancer and the role of their partners. Secondary objectives of the study are to identify possible differences between the partners in the areas of therapy, treatment goals, cognitive changes, health burden and partnership. The results should contribute to a better understanding of the therapy decision in this particular life situation and thus to an improved patient care. The study collective is to consist of 100 patients with advanced prostata cancer as well as their partners who visit the urological consultation at the National Center of Tumor Diseases and each of the complete their own questionnaire. The questionnaire consists of validated amamnestic, psychological, psycho-social and partnership-related items.

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Brief Summary in Scientific Language

Introduction: The choice of the right therapy is associated with different expectations and hopes of prostata cancer patients as well as for their Partners. So far their are particularly studies on the therapeutic decision-making of patients with first diagnosis of non-metastatic prostata carcinomas available. Increasing life expactancy and improved therapeutic options mean that older patients in an advanced stage of disease are progressively choosing between different oncological therapies. In these patients there are no study results available on the importance of the partnership. Objectives: The main objectives of the study is to record and describe the process of the therapy decision of patients with advanced prostata cancer and the role of their partners. Secondary objectives of the study are to identify possible differences between the partners in the areas of therapy, treatment goals, cognitive changes, health burden and partnership. The results should contribute to a better understanding of the therapy decision in this particular life situation and thus to an improved patient care. Subjects and methods: The study is a non-interventional exploratory study. The study collective is to consist of 100 patients with advanced prostata cancer as well as their partners who visit the urological consultation at the National Center of Tumor Diseases and each of the complete their own questionnaire. The questionnaire consists of validated amamnestic, psychological, psycho-social and partnership-related items.

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Organizational Data

  •   DRKS00013045
  •   2017/12/08
  •   [---]*
  •   yes
  •   Approved
  •   S511/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   The study group will consist of 100 patients with advanced prostate carcinoma and their 100 partners who will attend the urological consultation hours at the National Centre for Tumour Diseases and will complete questionnaires on anamnestic, psychological, psychosocial and partnership-related data. We use the validated questionnaires
    PHQ-4: (Leo et al. 2002).
    PA-F-KF: (Mehnert et al. 2006)
    ASKU: (Beierlein et al. 2012)
    QMI-D: (Zimmermann 2015)
    CPS: (Degner 1997)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The main objective of the study is to evaluate the process of therapy decision of patients with advanced prostate cancer and the role of partners using questionnaires PHQ-4, PA-F-KF, ASKU, QMI-D, CPS and other specific questions at the time of the prostate consultation.

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Secondary Outcome

As a secondary objective, possible differences between the questionnaire data of the partners in the areas of therapy decision, treatment goals, perception of cognitive changes, stress and partnership at the time of the prostate consultation are to be identified.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/11/30
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• German as mother language or high level in german language
• written informed consent
• Patient with the diagnosis prostata carcinoma in an advanced stage
• the patient visits the medical-oncological ambulance for a consultation with his partner.

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Exclusion Criteria

• Patient without an advanced prostata carcinoma
• Patient with an advanced prostata carcinoma who visits the consultation without his partner.

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Psychosomatische Universitätsklinik
    • Mr.  Dr. sc. hum.  Andreas  Ihrig 
    • INF 410
    • 69120  Heidelberg
    • Germany
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    • Psychosomatische Universitätsklinik
    • Mr.  Dr. sc. hum.  Andreas  Ihrig 
    • INF 410
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/03/20
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.